Senior Microbiologist

Fresenius Medical Care; Nilai; On-site; MYR 60,000 - 90,000; Full time

Job summary

A leading company in healthcare is seeking a microbiologist to conduct and manage microbiological testing, ensuring compliance with industry standards. Responsibilities include method development, training staff, and maintaining the quality of laboratory practices. Ideal candidates will have a strong background in microbiological testing and related regulatory requirements.

Qualifications

• Expertise in microbiological testing and compliance standards.
• Experience in method development and validation.
• Strong background in quality systems and regulatory guidelines.

Responsibilities

• Conduct and manage routine microbiological testing and method validation.
• Ensure regulatory compliance with cGMP, GLP, and relevant ISO standards.
• Oversee training and performance evaluation of microbiology staff.

Skills

Microbiological Testing

Method Development

Regulatory Compliance

Quality Improvement

Training

Job description

Routine Microbiological Testing

Conduct, manage, and lead routine microbiological testing of samples, including raw materials, in-process and finished products, and critical utilities (e.g., purified water systems).

Environmental Monitoring Program

Execute and coordinate the environmental monitoring program for classified manufacturing areas and support microbiological sampling and testing activities.

Laboratory Waste Management

Ensure proper disposal of microbiology laboratory waste and contaminated materials, including microorganism cultures, in accordance with established procedures.

Method Development and Validation

Lead, develop, conduct and coordinate analytical method validation for new or modified microbiological testing methods.

Material Qualification Testing

Lead, execute and coordinate microbiological testing activities related to material qualification.

Out-of-Specification (OOS) Investigations

Lead and manage microbiological lab OOS investigations, ensuring timely completion and submission of reports.

Non-Conformance Management

Investigate microbiology-related non-conformances, determine root causes, and implement corrective and preventive actions (CAPA) in accordance with company procedures.

Hygiene and Cleanroom Standards

Maintain the highest standards of hygiene in cleanrooms, laboratory areas, and equipment to prevent contamination.

Regulatory Compliance

Ensure full compliance with cGMP, GLP, ISO 13485, and ISO 17025 standards and guidelines.

SOP and Documentation Management

Develop, review, and update microbiological test methods and standard operating procedures (SOPs), ensuring Good Documentation Practices (GDP) are maintained.

Continuous Quality Improvement

Lead and participate in Quality Improvement Plans (QIP) aimed at enhancing quality systems, products, and services.

Training and Organizational Participation

Participate in company training programs and corporate activities, including safety, health, firefighting, and employee engagement events.

Staff Performance and Training

Monitor and evaluate staff performance, ensuring all microbiologists are adequately trained, competent, and motivated.

Audit Participation

Support compliance and regulatory audits (internal and external) in the role of auditor or auditee.

Document Review

Review microbiology laboratory documents, including test reports, protocols, and validation records.

Document Approval Support

Assist in the approval of microbiology-related documents in the absence of the Quality Control Manager.

Staff Qualification

Ensure all microbiology staff are trained, qualified, and competent in their assigned responsibilities.

Work Planning and Job Distribution

Oversee job distribution and work schedule arrangements within the Microbiology Laboratory.

Equipment Calibration and Maintenance

Manage calibration and preventive maintenance programs for laboratory equipment, ensuring timely execution.

Equipment Troubleshooting

Lead equipment troubleshooting efforts and coordinate with suppliers or vendors for technical support and service.

Other Duties

Perform any additional tasks or responsibilities as directed by management or immediate superior.